Post-Approval Monitoring & Regulatory Support Specialist
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About The Position
The Post-Approval Monitoring and Regulatory Support Specialist at The Ohio State University plays a crucial role in supporting the institutional accreditation of the Human Research Protection Program (HRPP). This position is responsible for ensuring efficient and compliant operations of the Institutional Review Board (IRB) and the Office of Responsible Research Practices (ORRP). The specialist will provide essential customer service to faculty, staff, and students engaged in human subjects research, facilitating a smooth and compliant research environment. Key responsibilities include facilitating the HRPP post-approval monitoring program, conducting educational post-approval monitoring visits as outlined in the post-approval monitoring plan, and collaborating with the ORRP's quality improvement (QI) team. The specialist will manage ongoing activities related to the university's HRPP accreditation, which includes developing and maintaining policies and guidance, as well as participating in quality improvement initiatives aimed at achieving compliance and efficiency goals. Additionally, the specialist will support IRB investigations, report findings of noncompliance with federal regulations and HRPP policies, and work closely with ORRP staff to review and resolve noncompliance issues. The role also involves facilitating IRB operations by receiving and screening non-exempt submissions, ensuring that all research activities adhere to established regulations and standards.
